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Treatment of Acetaminophen Toxicity With N-acetylcysteine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martha Blackford, Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00725179
First received: July 25, 2008
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.


Condition
Acetaminophen Toxicity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Treatment of Acetaminophen Toxicity With Intravenous vs Oral N-acetylcysteine: A Retrospective Review

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • Duration of oral vs IV NAC treatment in hours [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall healthcare costs associated with IV vs Oral NAC treatment [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients receiving oral NAC treatment
2
Patients receiving IV NAC treatment

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric and adolescent patients with acetaminophen toxicity

Criteria

Inclusion Criteria:

  • Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a qualifying ICD-9 diagnosis code for the following APAP overdose situations; poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0)
  • Serum APAP concentrations ≥ 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion
  • Between the ages of 0-21 years

Exclusion Criteria:

  • Serum APAP concentrations are not actually documented
  • Patient did not receive oral or IV NAC treatment
  • Patient has a preexisting liver disease such as cirrhosis or hepatitis C
  • Patient > 21 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725179

Locations
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44703
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Martha Blackford, PharmD CHMCA
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martha Blackford, PharmD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00725179     History of Changes
Other Study ID Numbers: APAP & NAC
Study First Received: July 25, 2008
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
acetaminophen toxicity
n-acetylcysteine
liver toxicity

Additional relevant MeSH terms:
Acetaminophen
Acetylcysteine
N-monoacetylcystine
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Antidotes
Antioxidants
Antipyretics
Antiviral Agents
Central Nervous System Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014